Tokyo, Jan. 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060212) titled 'Pemafibrate-Low-Density Lipoprotein Cholesterol Intervention Study' on Jan. 12.
Study Type:
Observational
Primary Sponsor:
Institute - Kindai University
Condition:
Condition - hyperlipidemia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to evaluate the effect of pemafibrate on LDL-C levels in patients with dyslipidemia who are receiving statin therapy, in a real-world clinical practice.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
100 mg/dL at the time of pemafibrate initiation
Individuals with triglyceride (TG) levels <400 mg/dL at the time of pemafibrate initiation
Individuals who received an explanation regarding study participation, fully understood the study, and provided written informed consent of their own free will
Key exclusion criteria - Patients who meet any of the contraindications for pemafibrate
Patients who had addition of, or a change in the dosage of, lipid-lowering medications within 12 weeks prior to the initiation of pemafibrate
Patients who had addition of, or a change in the dosage of, oral steroid preparations, thyroid hormone preparations, or antithyroid drugs within 12 weeks prior to the initiation of pemafibrate
Patients who are otherwise judged by the investigator to be unsuitable for participation in this study
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 10 Month 21 Day
Anticipated trial start date - 2025 Year 10 Month 21 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068850
Disclaimer: Curated by HT Syndication.
